Stress Disorders, Post-TraumaticPhase 3NCT00078767

Pharmacologic Treatment of PTSD in Sexually Abused Children

A Phase 3 study testing Trauma-Focused Cognitive Behavioral Therapy and Sertraline Pill in people with Stress Disorders, Post-Traumatic, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD). Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Trauma-Focused Cognitive Behavioral Therapy and Sertraline Pill
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Apr 2001to Mar 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Ages 10-17 years, inclusive
Confirmed sexual abuse
At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
Parent/primary caregiver available to participate in treatment
Assent with parental consent to participate

Who cannot join

Non-English speaking
schizophrenia or other severe psychotic disorder
MR (IQ<60) or PDD preventing CBT treatment
taking current psychotropic medication
documented substance dependence (substance abuse allowed)

Trial locations and contacts

1 site in 1 country.

United States1 site

Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

Read the detailed description

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Trauma-Focused Cognitive Behavioral Therapy, Sertraline Pill, Placebo Oral Tablet
Keywords: PTSD, Depression, Anxiety
Medical subject headings: Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trauma-Focused Cognitive Behavioral TherapyBehavioural
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline PillDrug
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral TabletDrug
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Study groups in NCT00078767
Study group	Role	What they receive
TF-CBT + sertraline	Experimental	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy; Drug: Sertraline Pill
TF-CBT +placebo	Active comparator	Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) Receives: Drug: Sertraline Pill; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.
Measured: Up to 39 months

Secondary outcomes (4)

Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Change in depressive symptoms as determined by change in score
Measured: Up to 39 months
Anxiety Symptoms
Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.
Measured: Up to 39 months
Global Impairment
Change in Children's Global Assessment Scale (CGAS) between the two groups
Measured: Up to 39 months
Incidence of Suicidality
Change in degree of suicidal ideation during study
Measured: Up to 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2001Mar 2006

First posted8 Mar 2004 (estimated)
Study startApr 2001
Primary completionMar 2006
Study completionMar 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00078767
Sponsor's protocol ID: K02MH001938
Other IDs: K02MH001938
Status last verified: Apr 2017
First submitted: 5 Mar 2004
Last updated: 5 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9. doi: 10.1097/chi.0b013e3180547105.
PubMed 17581445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stress Disorders, Post-Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacologic Treatment of PTSD in Sexually Abused Children
ClinicalTrials.gov ID: NCT00078767
Acronym / sponsor ID: K02MH001938
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD, Depression, Anxiety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Apr 2001
Primary completion: Mar 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 8 Mar 2004 (estimated)
Results: Posted 28 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TF-CBT + sertraline	Experimental	Behavioral: Trauma-Focused Cognitive Behavioral Therapy, Drug: Sertraline PillTrauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
TF-CBT +placebo	Active comparator	Drug: Sertraline Pill, Drug: Placebo Oral TabletTrauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Ages 10-17 years, inclusive
Confirmed sexual abuse
At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
Parent/primary caregiver available to participate in treatment
Assent with parental consent to participate

Key exclusion criteria (5 listed)

Non-English speaking
schizophrenia or other severe psychotic disorder
MR (IQ<60) or PDD preventing CBT treatment
taking current psychotropic medication
documented substance dependence (substance abuse allowed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trauma-Focused Cognitive Behavioral Therapy12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent	Behavioural	TF-CBT + sertraline
Sertraline Pill12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT	Drug	TF-CBT + sertraline, TF-CBT +placebo
Placebo Oral Tablet12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT	Drug	TF-CBT +placebo

Primary outcome

Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
Time frame: Up to 39 months
Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.

4 secondary outcomes

Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Time frame: Up to 39 months
Anxiety Symptoms
Time frame: Up to 39 months
Global Impairment
Time frame: Up to 39 months
Incidence of Suicidality
Time frame: Up to 39 months

Results and safety

Results posted to the registry on 28 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TF-CBT + Sertraline	12	11
TF-CBT +Placebo	12	11

Primary outcome: Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD

Time frame: Up to 39 months. Count of participants. Unit: Participants

Measure	TF-CBT + Sertraline n = 11	TF-CBT +Placebo n = 11
PTSD diagnosis at enrollment but no PTSD at end	8	6
PTSD at enrollment and PTSD at end	1	5
No PTSD diagnosis at enrollment and no PTSD at end	2	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 39 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TF-CBT + Sertraline	0 of 11 (0%)	0 of 11 (0%)	0 of 11
TF-CBT +Placebo	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17581445Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9. doi: 10.1097/chi.0b013e3180547105.
National Child Traumatic Stress NetworkLink provided by the sponsor.

Related trials for Stress Disorders, Post-Traumatic

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith A Cohen, M.D. principal investigator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD (time frame: Up to 39 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.